Electrical safety tester RIGEL 62353
The Rigel 62353’s compact lightweight design and long life battery power reduces downtime between tests, making the instrument practical and highly portable for multi-site use.
The Rigel 62353 tests to the new standard for in-service and after repair testing of medical electronic devices, the IEC 62353 (2007). The Rigel 62353’s large internal memory facilitates the storage of test results for safety audit and traceability purposes. Comprehensive database software is available to ensure fast and easy download of test results, managing your asset database, creation of test sequences, scheduling of Preventative Product Maintenance and producing test certificates. Stored data can be transferred immediately and directly from the tester to PC-based record keeping systems at the touch of a button. The highly versatile Rigel 62353 represents the next generation of electrical medical safety analyzers.
hand-held medical safety testers has changed. The globally recognized IEC 62353 has become the general guideline for routine testing for many leading medical device
manufacturers. Newer faster and easier test methods can be maintained using the IEC
62353 standard. The Rigel 62353 combines the requirements for the IE62353 and AAMI/NFPA or AS/NZ3551 leakage currents (local variants only) as well as the new IEC 62353. The Rigel 62353 is the first dedicated IEC 62353 safety analyzer that is able to provide automatic sequencing, onboard data storage and data entry in a ergonomic hand-held
enclosure. This will allow for high flexibility in the field.
The Market Place
With the introduction of the IEC 62353 standard for in-service and after-repair testing
of medical electronic devices, the market for includes a unique feature to allow visual or
acceptance test routines to be configured prior to an electrical safety test. These could
be simple instructions to the user or observations required for your own
maintenance procedures such as checking for certain labels, software versions and
upgrades etc. In addition, you can configure post safety test procedures such as recording readings during a performance test on a patient monitor (SpO2, NiBP, ECG, Temperature,
IBP etc.) or defibrillators (energy, synch time, charge time etc.) and so on. These features make the Rigel 62353 a truly versatile service tool to ensure all test data is captured and processed in one single test record, thus maximizing traceability and allowing full flexibility in the field.
Custom Test Settings
The unique setup in the Rigel 62353 not only allows you to configure your own test sequences or modify existing ones to suit your specific needs, the Rigel 62353 also
Create customer test routines including test protocols for testing patient monitors (NIBP,
SpO2, ECG tc.), defibrillators etc. Test protocols can be easily uploaded to the
Rigel 62353. Use the Rigel 62353 during functional testing to collect not only the electrical safety test record but also the performance of the medical device. The complete PPM in one
single record. Furthermore, the software allows you to produce certificates and print or email them to make sure test records are kept for future reference.
Key Features
1.Windows Explorer type user interface - layout
2.Download from Rigel 62353 to a PC
3.Upload from PC to Rigel 62353
4.Create test routines and configure multiple testers
5.Output of database to Excel / Access.
6.Database function
7.Test schedule function
8.Printing of test certificate
9.Store test certificate as HTML for easy email application
Med-eBase PC Software
The Rigel 62353 is compatible with Med-eBase, a new and comprehensive download software package capable of producing asset management records and work schedules.
Use the software to configure a number of Rigel 62353s at the same time to ensure that
all engineers work to the same test routines.
Rigel 62353 Design Philosophy
The Rigel 62353 has been designed to address the increasing demand for smaller more comprehensive test equipment within the healthcare industry. What better way than
to combine such a tester with the International In-Service Test required as per
IEC 62353. The challenge was to unite the benefits of the size and weight of a smaller hand-held and portable analyzer with the test power and convenience of a larger bench-mounted
automatic safety analyzer. Today’s industry demands test equipment that can save time
and money. These factors have been taken into account during the development of the
Rigel 62353. The test capabilities and functionality exceed that of most common
bench mounted safety analyzers, yet the instrument is only a fraction of the size
and weight. No other safety tester on the market offers a hand-held enclosure with the test capabilities of an automatic safety analyzer; including IEC 62353 leakage tests, up to 2 patient connections, alpha-numeric keyboard, graphic user interface, large internal memory,
PC communication, asset management facilities, user configurable performance tests
and more. We believe that the new Rigel 62353 is set to become the new standard in electrical medical safety testing.
Seaward Group files patent for new
Earth Continuity test
Seaward Group, parent company of Rigel Medical, has developed a new method of
carrying out earth continuity tests undertaken as part of the process to verify the electrical safety of portable medical and domestic appliances. The Seaward Group has filed a patent
application for the new test technology that uses a dual current high intensity test to
overcome contact resistance problems or other situations where weak conductor
connections may inhibit protective earth testing with conventional test currents such
as 1A or 200mA. The patent recognizes that a 200mA test current is rapidly becoming the international standard for in-service testing and testing after repair of medical electronic equipment such as the IEC 62353. However, the new concept has been specially designed to help overcome variations in measurement that can be caused by contact resistance between the test probe and the device under test, for example, when measuring continuity of
tarnished or corroded parts often seen in the commonly used detachable IEC power
cable. The unique technology introduced by Seaward Group enables valid earth continuity
tests to be carried out using battery powered testers and is being incorporated into the
new Rigel 62353 hand held electrical medical safety analyzer. The innovative new Rigel 62353 has been specifically designed to provide a hand-held test solution for those demanding versatility and portability yet not compromising the validity of tests being carried out. The Rigel 62353 meets the in-service and post-repair test demands of the IEC 60601 and IEC 62353 standard for in-service testing of Medical Devices.
SPECIFICATIONS
Earth Continuity
Method 2 wire technique, using 'zero' lead function.
Test Current >+200mA, -200mA DC into 2 ohms
Max Test Voltage 4-24V rms o/c (6V for IEC 60601 tests)
Measuring Range (low range) 0.001 – 0.999 ohms @ 0.001 ohms resolution
Measuring Range (mid range) 1.00 – 9.99 ohms /@ 0.01 ohms resolution
Measuring Range (high range) 10.0 – 19.9 ohms @ 0.1 ohms resolution
Accuracy ± 3% of reading + 10 m ohms
Insulation Resistance
Measurement EUT to Earth / Ground, EUT to AP, AP to Ground
Voltage 250V DC, 500 V DC @1mA.
Range (low range) 0.01Mohms - 20 Mohms
Accuracy (low range) ± 5% of reading +2 counts
Range (high range) 20Mohms – 100Mohms
Accuracy (high range) ±10% +2 counts
Resolution 0.01Mohms
Direct Leakage Measurement
Measuring Range 4µA to 9999µA
Accuracy ± 5% or reading +2 counts
Mains on A.P. voltage F-type only @ 100% of mains
Measuring Device As per IEC 60601-1 requirements
Measurement Type True RMS
Differential Leakage Measurement
Measuring Range 75µA to 9999µA
Accuracy ±5% of reading + 5 counts
Measurement / display/ resolution 1µA
Measurement Type True RMS
Measuring Device Similar frequency response characteristics to IEC 60601-1.
Alternative Leakage Measurements
Test Voltage 250V at mains frequency
Test Current 3.5 mA current limited
Measurement Range 4µA to 9999µA
Measurement Resolution 1µA
Measurement Accuracy ±5% of reading + 2 counts
Measurement Type True RMS
Measuring Device As per IEC 60601-1
Power Measurement
Method VA rating.Range 0.1KVA – 4KVAAccuracy ±10% + 2 countsMains Outlet Test Input voltage range: 0-300V AC, max current 16A
Measures L – E, N – E & L – N
Accuracy ± 5% of reading + 2 counts
IEC Mains Lead Test
Test Duration: 2s
Test: Continuity of all conductors, Earth bond, Insulation & Polarity
General
Mains power 230 VAC ±10%, 50Hz +/- 1Hz
120 VAC ±10%,
60Hz +/- 1Hz (USA model)
Battery 6 x 1.5V Alkaline AA
Weights 1.6 kg including batteries
Size (L x W x D) 270 x 110 x 75 mm / 10.5 x 4 x 3”
Operating conditions 0' - 40'C, 0-90% RH - NC
Storage environment -15' - +60'C
Environmental Protection IP 40
The Rigel 62353’s compact lightweight design and long life battery power reduces downtime between tests, making the instrument practical and highly portable for multi-site use.
The Rigel 62353 tests to the new standard for in-service and after repair testing of medical electronic devices, the IEC 62353 (2007). The Rigel 62353’s large internal memory facilitates the storage of test results for safety audit and traceability purposes. Comprehensive database software is available to ensure fast and easy download of test results, managing your asset database, creation of test sequences, scheduling of Preventative Product Maintenance and producing test certificates. Stored data can be transferred immediately and directly from the tester to PC-based record keeping systems at the touch of a button. The highly versatile Rigel 62353 represents the next generation of electrical medical safety analyzers.
hand-held medical safety testers has changed. The globally recognized IEC 62353 has become the general guideline for routine testing for many leading medical device
manufacturers. Newer faster and easier test methods can be maintained using the IEC
62353 standard. The Rigel 62353 combines the requirements for the IE62353 and AAMI/NFPA or AS/NZ3551 leakage currents (local variants only) as well as the new IEC 62353. The Rigel 62353 is the first dedicated IEC 62353 safety analyzer that is able to provide automatic sequencing, onboard data storage and data entry in a ergonomic hand-held
enclosure. This will allow for high flexibility in the field.
The Market Place
With the introduction of the IEC 62353 standard for in-service and after-repair testing
of medical electronic devices, the market for includes a unique feature to allow visual or
acceptance test routines to be configured prior to an electrical safety test. These could
be simple instructions to the user or observations required for your own
maintenance procedures such as checking for certain labels, software versions and
upgrades etc. In addition, you can configure post safety test procedures such as recording readings during a performance test on a patient monitor (SpO2, NiBP, ECG, Temperature,
IBP etc.) or defibrillators (energy, synch time, charge time etc.) and so on. These features make the Rigel 62353 a truly versatile service tool to ensure all test data is captured and processed in one single test record, thus maximizing traceability and allowing full flexibility in the field.
Custom Test Settings
The unique setup in the Rigel 62353 not only allows you to configure your own test sequences or modify existing ones to suit your specific needs, the Rigel 62353 also
Create customer test routines including test protocols for testing patient monitors (NIBP,
SpO2, ECG tc.), defibrillators etc. Test protocols can be easily uploaded to the
Rigel 62353. Use the Rigel 62353 during functional testing to collect not only the electrical safety test record but also the performance of the medical device. The complete PPM in one
single record. Furthermore, the software allows you to produce certificates and print or email them to make sure test records are kept for future reference.
Key Features
1.Windows Explorer type user interface - layout
2.Download from Rigel 62353 to a PC
3.Upload from PC to Rigel 62353
4.Create test routines and configure multiple testers
5.Output of database to Excel / Access.
6.Database function
7.Test schedule function
8.Printing of test certificate
9.Store test certificate as HTML for easy email application
Med-eBase PC Software
The Rigel 62353 is compatible with Med-eBase, a new and comprehensive download software package capable of producing asset management records and work schedules.
Use the software to configure a number of Rigel 62353s at the same time to ensure that
all engineers work to the same test routines.
Rigel 62353 Design Philosophy
The Rigel 62353 has been designed to address the increasing demand for smaller more comprehensive test equipment within the healthcare industry. What better way than
to combine such a tester with the International In-Service Test required as per
IEC 62353. The challenge was to unite the benefits of the size and weight of a smaller hand-held and portable analyzer with the test power and convenience of a larger bench-mounted
automatic safety analyzer. Today’s industry demands test equipment that can save time
and money. These factors have been taken into account during the development of the
Rigel 62353. The test capabilities and functionality exceed that of most common
bench mounted safety analyzers, yet the instrument is only a fraction of the size
and weight. No other safety tester on the market offers a hand-held enclosure with the test capabilities of an automatic safety analyzer; including IEC 62353 leakage tests, up to 2 patient connections, alpha-numeric keyboard, graphic user interface, large internal memory,
PC communication, asset management facilities, user configurable performance tests
and more. We believe that the new Rigel 62353 is set to become the new standard in electrical medical safety testing.
Seaward Group files patent for new
Earth Continuity test
Seaward Group, parent company of Rigel Medical, has developed a new method of
carrying out earth continuity tests undertaken as part of the process to verify the electrical safety of portable medical and domestic appliances. The Seaward Group has filed a patent
application for the new test technology that uses a dual current high intensity test to
overcome contact resistance problems or other situations where weak conductor
connections may inhibit protective earth testing with conventional test currents such
as 1A or 200mA. The patent recognizes that a 200mA test current is rapidly becoming the international standard for in-service testing and testing after repair of medical electronic equipment such as the IEC 62353. However, the new concept has been specially designed to help overcome variations in measurement that can be caused by contact resistance between the test probe and the device under test, for example, when measuring continuity of
tarnished or corroded parts often seen in the commonly used detachable IEC power
cable. The unique technology introduced by Seaward Group enables valid earth continuity
tests to be carried out using battery powered testers and is being incorporated into the
new Rigel 62353 hand held electrical medical safety analyzer. The innovative new Rigel 62353 has been specifically designed to provide a hand-held test solution for those demanding versatility and portability yet not compromising the validity of tests being carried out. The Rigel 62353 meets the in-service and post-repair test demands of the IEC 60601 and IEC 62353 standard for in-service testing of Medical Devices.
SPECIFICATIONS
Earth Continuity
Method 2 wire technique, using 'zero' lead function.
Test Current >+200mA, -200mA DC into 2 ohms
Max Test Voltage 4-24V rms o/c (6V for IEC 60601 tests)
Measuring Range (low range) 0.001 – 0.999 ohms @ 0.001 ohms resolution
Measuring Range (mid range) 1.00 – 9.99 ohms /@ 0.01 ohms resolution
Measuring Range (high range) 10.0 – 19.9 ohms @ 0.1 ohms resolution
Accuracy ± 3% of reading + 10 m ohms
Insulation Resistance
Measurement EUT to Earth / Ground, EUT to AP, AP to Ground
Voltage 250V DC, 500 V DC @1mA.
Range (low range) 0.01Mohms - 20 Mohms
Accuracy (low range) ± 5% of reading +2 counts
Range (high range) 20Mohms – 100Mohms
Accuracy (high range) ±10% +2 counts
Resolution 0.01Mohms
Direct Leakage Measurement
Measuring Range 4µA to 9999µA
Accuracy ± 5% or reading +2 counts
Mains on A.P. voltage F-type only @ 100% of mains
Measuring Device As per IEC 60601-1 requirements
Measurement Type True RMS
Differential Leakage Measurement
Measuring Range 75µA to 9999µA
Accuracy ±5% of reading + 5 counts
Measurement / display/ resolution 1µA
Measurement Type True RMS
Measuring Device Similar frequency response characteristics to IEC 60601-1.
Alternative Leakage Measurements
Test Voltage 250V at mains frequency
Test Current 3.5 mA current limited
Measurement Range 4µA to 9999µA
Measurement Resolution 1µA
Measurement Accuracy ±5% of reading + 2 counts
Measurement Type True RMS
Measuring Device As per IEC 60601-1
Power Measurement
Method VA rating.Range 0.1KVA – 4KVAAccuracy ±10% + 2 countsMains Outlet Test Input voltage range: 0-300V AC, max current 16A
Measures L – E, N – E & L – N
Accuracy ± 5% of reading + 2 counts
IEC Mains Lead Test
Test Duration: 2s
Test: Continuity of all conductors, Earth bond, Insulation & Polarity
General
Mains power 230 VAC ±10%, 50Hz +/- 1Hz
120 VAC ±10%,
60Hz +/- 1Hz (USA model)
Battery 6 x 1.5V Alkaline AA
Weights 1.6 kg including batteries
Size (L x W x D) 270 x 110 x 75 mm / 10.5 x 4 x 3”
Operating conditions 0' - 40'C, 0-90% RH - NC
Storage environment -15' - +60'C
Environmental Protection IP 40
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